System and method for additive manufacture of medical devices

ABSTRACT

An additive manufacturing system is capable of extruding poly-fiber strand having a fiber core coated with a polymer with a high range of flexibility in positioning and orienting extruded fibers. Extruded fibers may be laid in a single direction, or may curve or turn to be laid in multiple directions. Structures of devices and components may be created using interconnected extruded strands having interstitial spaces between and around the strands. This structure may be infused with resin or polymer using a pressure or vacuum based infusion system. In this manner, durable polymeric objects can be created without requiring expensive molds. Other techniques are also possible, including varying the types of strands used in an object to create areas of the object that will preferentially twist or flex in certain ways or directions, as well as producing objects with zones having different types of resin or no resin.

FIELD

The disclosed technology pertains to a system for additive manufacturingof devices, components, and other objects.

BACKGROUND

Due to the applications and environments that they are used within, itmay be advantageous for some medical devices to be manufactured usingpolymeric materials instead of metal. The use of polymeric materials mayallow for reduced cost of acquiring materials, reduced cost ofprocessing raw materials, or both. Polymeric materials may haveadditional advantages, including reduced weight, which may be desirablefor implants, prosthetics, and handheld tools, a reduced change ofallergic reaction or related reactions in the case of implants andprosthetics, and improved resistance to rust, corrosion, and other wearthat may occur when used in biological applications.

A limitation of polymeric materials that has limited their widespreaduse is a decreased mechanical strength relative to metallic materials.The strong forces that tools, implants, prosthetics and other objectsundergo during use may cause conventional polymeric components to failin ways that may be dangerous and unpredictable. Even where traditionalpolymeric components may meet the requirements for mechanical strength,their cost advantages may go unrealized, especially in cases where theyare only needed in limited quantities. For example, polymeric componentsthat are mass produced may be able to spread the cost of custom moldsused during their manufacture across many produced items, whereas customimplants or prosthetics that require a unique mold may only be able tospread those costs over a handful of produced items.

Additive manufacturing techniques may be used to produce medical devicesthat achieve the benefits noted above, while also enabling thecustomization of medical devices such that a given medical device may bestructurally configured ad hoc based on anatomy and/or needs of theparticular patient for whom the medical device will be used. What isneeded, therefore, is an improved system for the additive manufacture ofmedical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings and detailed description that follow are intended to bemerely illustrative and are not intended to limit the scope of theinvention as contemplated by the inventors.

FIG. 1 is a flowchart of a set of high-level steps in an exemplarymethod that could be performed by or with a system to additivelymanufacture a piece;

FIG. 2 is a flowchart of a set of exemplary sub-steps that could beperformed within the method of FIG. 1 to create a substructure for thepiece;

FIG. 3 is a schematic diagram of an exemplary feed system for feedingpolymer coated fiber to an extrusion head of an additive manufacturingsystem that may be used to perform the method of FIG. 1;

FIG. 4 is a schematic diagram of an exemplary additive manufacturingsystem that may be used to perform the method of FIG. 1;

FIG. 5 is a schematic diagram of the additive manufacturing system ofFIG. 1 and an exemplary manufactured piece;

FIG. 6 is a cross section of an exemplary polymer die of the additivemanufacturing system of FIG. 4;

FIG. 7 is a front perspective view of the manufactured piece of FIG. 5;

FIG. 8 is a front perspective view of several extruded poly-fibersduring an additive manufacturing process;

FIG. 9 is a side elevation view of the extruded poly-fibers of FIG. 8;

FIG. 10 a perspective view of several extruded and shaped poly-fibersduring an additive manufacture process;

FIG. 11 is a flowchart showing an exemplary set of steps that theadditive manufacturing system of FIG. 1 could perform to create a pieceusing an additively manufactured substructure;

FIG. 12 is a front perspective view of an exemplary mold resin-transferprocess at a first stage;

FIG. 13 is a front perspective view of the mold resin-transfer processof FIG. 12 at a second stage;

FIG. 14 is a side cross sectional view of an exemplary piecemanufactured using the process of FIGS. 12 and 13;

FIG. 15 is a side elevation view of an exemplary resin-infusion process;

FIG. 16 is a side elevation view of an exemplary piece manufacturedusing the process of FIG. 15;

FIG. 17 is a front perspective view of an exemplary piece manufacturedusing one of the processes of FIG. 12 or 15, with dotted lines showingan internal structure;

FIG. 18 is a side cross sectional view of another exemplary piecemanufactured using one of the processes of FIG. 12 or 15, with solidlines showing an internal structure;

FIG. 19 is a top cross sectional view of the manufactured piece of FIG.18 taken along line 19-19 of FIG. 18, with solid lines showing aninternal structure;

FIG. 20 shows an exemplary set of steps that could be performed by anadditive manufacturing system to produce a manufactured piece withvariable stiffness;

FIG. 21 is a cross-sectional view of an exemplary manufactured pieceshowing areas having variable stiffness based upon the rigidity ofindividual filaments used;

FIG. 22 is a cross sectional view of an exemplary manufactured pieceshowing areas having variable stiffness based upon the type or absenceof resin used;

FIG. 23A is a cross sectional view of an exemplary manufactured pieceshowing an area having variable stiffness based upon the type or absenceof resin used;

FIG. 23B is a cross sectional view of another exemplary manufacturedpiece showing an example of an area having variable stiffness based uponthe type or absence of resin used;

FIG. 23C is a cross sectional view of another exemplary manufacturedpiece showing an example of an area having variable stiffness based uponthe type or absence of resin used; and

FIG. 23D is a cross sectional view of another exemplary manufacturedpiece showing an example of an area having variable stiffness based uponthe type or absence of resin used.

DETAILED DESCRIPTION

The inventors have conceived of novel technology that, for the purposeof illustration, is disclosed herein as applied in the context ofsystems and techniques for additive manufacturing. While the disclosedapplications of the inventors' technology satisfy a long-felt but unmetneed in the art of additive manufacturing, it should be understood thatthe inventors' technology is not limited to being implemented in theprecise manners set forth herein, but could be implemented in othermanners without undue experimentation by those of ordinary skill in theart in light of this disclosure. Accordingly, the examples set forthherein should be understood as being illustrative only, and should notbe treated as limiting.

The disclosed technology may be used to additively manufacture medicaldevices or components of medical devices from polymeric materials ratherthan metallic materials. The strengths and structural characteristics ofproduced devices may be varied throughout the structure to provide anelevated level of flexibility in some portions of the device and anelevated level of rigidity in others. Additive manufacturing of thedevices requires a novel system that is capable of performing apultrusion process to extrude a polymer coated fiber (poly-fiber) thatmay be bound with other poly-fibers through the heating and cooling ofthe polymer coating. As each length of extruded poly-fiber is placed, acutter placed proximately to the extrusion nozzle cuts the extrudedpoly-fiber. In this manner, a porous substructure of the device may becreated from one or more types of poly-fibers. The extrusion nozzle iscapable of a wide range of movement and rotation to allow for devices ofvarious size and structure to be manufactured, and to allow for a widerange of poly-fiber directionality, which allows for optimization offorce vectors within the devices structure. The completed substructurethen undergoes a resin impregnation process that fills the porous areasof the substructure with one or more types of polymeric materials thatmay be cured or hardened.

A variety of devices and components may be created from polymericmaterials in this way, with the created devices having an increasedstrength and durability compared to molded polymer devices due to theembedded substructure, which may be custom designed for each device toprovide favorable disposition and directionality of fibers for thatdevice. Due to the range of options available in the types of fiber used(e.g., carbon, glass, aramid), the types of polymers used, and theflexibility of fiber disposition and directionality, the types ofdevices or components that may be produced in this manner are nearlylimitless.

As a few non-limiting examples, this could include custom designed orshaped surgical meshes or structures for hernia surgery similar to thoseoffered under the names Prolene®, Mersilene®, and Ultrapro®, customsized and shaped surgical meshes for uterine and pelvic surgery similarto those offered under the names Artisyn® and Gynecare Gynemesh®, customsized and shaped pelvic implants such as those offered under the namesGynecare TVT Exact®, Gynecare TVT Abbrevo®, and Gynecare TVT™. Thiscould also include custom sized and shaped grips, handles, or casingsfor surgical instruments such as those sold under the names HarmonicWave®, Harmonic Synergy®, Enseal®, Echelon Flex™, Proximate®, andothers, which could allow for those devices to be fitted with customparts to provide a particular user a custom-fitted or desired grip,handle, shape, or size according to their preference. Other devices andcomponents could include custom sized and shaped components of sinuscatheter systems such as those sold under the name Relieva Ultirra®,custom sized and shaped hip implants such as those sold under the namesActis®, Corail®, Pinnacle®, Reclaim®, Summit®, and Tri-Lock®, and othercustom sized and shaped implants and fixation systems such as those soldunder the names Biointrafix®, Femoral Intrafix™, Gryphon®, and HealixAdvance™. Other devices and components that may advantageously beadditively manufactured using one or more of the systems and techniquesdescribed herein will be apparent to those of ordinary skill in the artin light of the disclosure herein. It should also be understood that,when additive manufacturing is used to produce an ad hoc medical device(or an ad hoc component for a medical device), the medical device (orcomponent thereof) may be customized based on the particular patientwith whom the medical device will be used; and/or based on theparticular physician who will be using the medical device.

FIG. 1 shows a set of high level steps that could be performed by orwith an additive manufacturing system (101), such as that shown in FIGS.4 and 5, to additively manufacture a device, component, part, or otherobject. Initially, a part definition will be received (block 300) by acontroller or processor of the additive manufacturing system (101). Thepart definition will define the coordinates of a substructure orframework of the part. This will include the placement, orientation,length, and characteristics of poly-fibers that will make up thesubstructure, and will be in a format that may be interpreted by thecontroller or processor of the additive manufacturing system (101) andused by the additive manufacturing system (101) to position and orientthe extrusion head (200), extrude one or more types of poly-fiber, andcut a recently extruded poly-fiber with a cutter (110) proximate to theextrusion head. Once received, the part definition will be used by theadditive manufacturing system (101) to manufacture (block 302) thesubstructure by extruding poly-fiber one fiber and one layer at a time,with extruded poly-fibers building upon and adhering to previouslyplaced fibers as the heated polymer coating cools and solidifies.

While the examples and descriptions herein refer to a substructure, itshould be understood that the disclosed technology could also be used tocreate superstructures for objects, or structures that combinesuperstructures and substructures. For example, a producedsuperstructure could be a “skin” or outer-structure of an object thatmay undergo a resin impregnation process. In this manner, a poroussuperstructure that surrounds an interior hollow could be produced.During resin impregnation, the porous outer layer would form apoly-fiber reinforced skin that wraps around a resin filled hollow.Structures combining elements of superstructures and substructures arealso possible. For example, a produced structure could have both aporous superstructure skin, and a porous substructure within. Duringresin impregnation, such a structure could have a poly-fiber reinforcedskin that wraps around a poly-fiber reinforced interior, and may alsocontain resin filled hollow areas. As can be seen, this allows for greatflexibility and variety in the types of structures that can be produced,and great flexibility in the characteristics of objects that can beproduced by resin impregnation of these structures.

Once the manufactured substructure is completely placed, and fullycooled or solidified, the substructure may be placed (block 304) in aresin impregnation system. The particular actions involved in placement(block 304) will vary by the particular type of resin impregnationprocess. This could include a pressure resin impregnation process,whereby the substructure may be placed into a mold or bath and resinwill be injected into the structure under pressure to push air out ofthe porous substructure and replace it with a liquid resin or polymer.This could also include a vacuum resin impregnation process, whereby thesubstructure may be placed into a bag or other air tight container witha liquid resin or polymer input, and then air may be forcefully removedfrom the porous substructure, which will cause the liquid polymer to bedrawn into the porous substructure. So, in some cases placing (block304) and preparing the substructure could include placing thesubstructure in a mold, resin bath, vacuum bag, or other container orsystem that a resin impregnation process might use. Once prepared, aresin impregnation process may be performed (block 306), which willgenerally involve removing air from the porous substructure andreplacing it with a liquid resin or polymer. Once the resin impregnationprocess (block 306) is complete, and the liquid has cured or solidified,the result will be a hardened polymer part with an embeddedsubstructure, with the overall shape of the part generally matching theshape of the substructure, the shape of a mold or vacuum bag used in theprocess, or both.

FIG. 2 shows a set of high level steps that may be performed by anadditive manufacturing system (101) to create a substructure orframework for the manufactured piece. Initially, strands of poly-fibermust be produced by feeding strands of fiber (block 308) and applyingpolymer (block 310) to the fiber as it is fed, in a technique known aspultrusion. FIG. 3 shows one example of a pultrusion feed system (100),comprising a fiber feed (102) that is a spool of fiber or a roller thatpulls from a spool of fiber (block 308). As fiber is fed from the fiberfeed (102), the fiber is pulled through a polymer bath (104) where aliquid polymer coats (block 310) the fiber strands. As the poly-fiberexits the polymer bath (104), a poly-fiber feed (106) spools and feeds,or feeds, the poly-fiber downstream. FIG. 4 shows an alternateimplementation of the pultrusion system. That figure shows a fiber feed(102) that feeds fiber strands to a polymer die (108) that coats strandsthat are pulled through it with polymer.

FIG. 6 shows a cross-section view of the polymer die (108), whichcomprises a polymer input (116) that feeds into a primary channel (117),a fiber input (118) having a seal (120) allows fiber to pass into theprimary channel (117) while preventing backflow of polymer into thefiber input (118), and a poly-fiber output (122) at the exit of theprimary channel (117). Fiber may be fed into the polymer die (108) byone or more of being fed by a fiber feed (102), pulled through thepolymer die by a spool or roller on the output (122) end of the polymerdie (108), pulled through the polymer die (108) by the flow of injectedpolymer, or other feed methods. As the fiber is pulled through thepolymer die (108), the fiber is coated in polymer that takes on theshape of the primary channel (117) of the polymer die (108). The polymerinjection (116) may be combined with a heat source to heat the polymerat the injection point to improve flow, and the side walls of primarychannel (117) will cool the polymer as it travels along the primarychannel (117) by drawing heat out of the polymer and transferring it tothe rest of the body of the polymer die (108).

The polymer bath pultrusion system of FIG. 3 may also be combined withthe polymer die (108) shown in FIG. 6. For example, a polymer bath (104)could be used to apply a first type or application of polymer to thefiber, which could then be fed into the polymer die (108), where itcould then receive a second type or application of polymer and be shapedin the primary channel (117), or could be heated and shaped in theprimary channel (117), or both. This could allow different types ofpolymers to be applied in layers, or could allow the bulk of the polymerto be applied by the polymer bath (104) with a second application beinginjected into the polymer die (108), while allowing the producedpoly-fiber to be heated and shaped by the mold so that the resultingpoly-fiber is coated, sized, and shaped consistently.

The process of feeding (block 308) and coating (block 310) thepoly-fiber can be performed at the same speed that the coated poly-fiberis extruded during manufacturing. In this manner, the extrusion head(200) can be positioned, oriented, and used to deposit (block 312) arecently coated length of poly-fiber while a subsequent length of fiberis being coated (block 310) with polymer. Positioning and orienting theextrusion head (200) may involve movement or rotation of one or more ofa rastering system, a mechanical arm, or a manufacturing space platformto allow for up to six degrees of freedom for the extrusion head (200)within the manufacturing space both before and during extrusion of apoly-fiber. Extruded poly-fiber may be hot enough for the polymercoating to adhere as it exists the polymer die (108), or it may bere-heated by a heat source such as a heated surface or heated blower asit leaves the polymer die (108). The type of heat source and the heatneeded to prepare the polymer coating for adhesion to other poly-fiberswill vary based upon the particular type of fiber and polymer used, aswell as the desired speed of extrusion. The initial strands or layers ofpoly-fiber may be extruded onto a flat or contoured surface of themanufacturing space, with subsequent layers being laid on top, adheringand then solidifying as they cool to form a permanent bond.

As the end point of each strand is deposited (block 312), a cutter (110)may be actuated to sever (block 314) the placed length of poly-fiberfrom the unplaced length of poly-fiber. The cutter (110) is located nearthe extrusion head (200), and may include, for example, a cutting bladethat may be extended to press the poly-fiber against a cutting block andsever it, two cutting blades that extend and trap the poly-threadbetween them to sever it, three or more blades arranged so that that maybe extended to trap the poly-fiber in a triangular, square, or othergeometrical arrangement and sever it, one or more curved blades that maybe extended towards each other or towards a cutting block to trap thepoly-fiber and sever it, or a variation of any one or more of the above.Different arrangements of cutting blades and cutting surfaces will beadvantageous for different types of fiber and polymer, and suchvariations will be apparent to one of ordinary skill in the art in lightof the disclosure herein.

FIG. 5 shows a diagrammatic view of the additive manufacturing system(101), where the extrusion head (200) is positioned and oriented toplace a deposit strand (114) of poly-fiber (206) at a manufactured piece(112). FIG. 5 also shows a polymer injector (109) that may be used toinject polymer into the polymer die (108), heat polymer that is beinginjected into the polymer die (108) or that is already present in thepolymer die (108) (i.e., is already coated on a fiber from a bath(100)), or both. FIG. 7 shows an example of a manufactured piece (112)that could be created using the additive manufacturing system (101). Thestructure of the poly-fibers and the high level of freedom with whichthe extrusion head (200) may be positioned and oriented allows forvariable placement and directionality of the deposited poly fiberstrands. For example, the manufactured piece (112) is created from acombination of rows of horizontally placed poly-fibers (126) and columnsof vertically placed poly-fibers (124), that are adhered to each otherby polymer coating that has been heated at deposit and then allowed tocool. This differs from conventional additive manufacturing techniques,which rely upon the repeated placement of a single texture filament inhorizontal layers, and is made possible by both the structure providedby the poly-fiber compared to conventional filament, and the high degreeof freedom of the extrusion head (200).

FIGS. 8 and 9 show examples of interconnected poly-fiber strands. Thefiber material (202) and polymer layer (204) can be seen at the cut endsof the poly-fibers. An extruded poly-fiber (206) is shown beingdeposited by the extrusion head (200) so that extruded poly-fiber (206)lays across multiple base poly-fibers (205), and a bonding point (208)forms at each point where the extruded poly-fiber (206) touches a basepoly-fiber (205). FIGS. 7 and 8 also show a direction change (207),where the extruded poly-fiber (206) may change direction duringdeposition. This is possible because the polymer casing is still in amolten state when the polymer casing is first deposited, but as thepolymer casing cools it will stiffen and become less flexible. Coolingcould occur naturally, or could occur due to directed blasts of coolingair from an external blower or a blower mounted proximately to theextrusion head (200). By extruding a length of poly-fiber (206) andallowing the extruded poly-fiber (206) cool to the point that it becomesless flexible, a change in directionality may occur (207) as shown inFIGS. 7 and 8.

FIG. 10 shows a set of interconnected poly-fiber strands (214, 216) thatinclude both unidirectional strands (214) and multidirectional strands(216). In the shown example, a grid of unidirectional strands (214)forms a first layer (210) and part of a second layer (212), whichprovides a stable area for a multidirectional strand (216) to bedeposited. The multidirectional strand (216) is formed by depositing apoly-fiber strand onto the first layer (210), and positioning andorienting the extrusion head (200) throughout the deposition to includeone or more directional changes (207). The advantage of includingmulti-directional strands in addition to a gridwork of unidirectionalstrands is that it provides an increased volume and variety ofinterstitial spaces (209) in the resulting part that may providebenefits when used as a substructure during a polymer or resinimpregnation process (block 306). Being able to vary the directionalityof strands (207), and the shape of the resulting interstitial spaces(209), allows the rigidity and flexibility of the resin-impregnatedsubstructure to be customized as desirable.

With a customized substructure having been produced by the additivemanufacturing system (101), a resin impregnation process may then beperformed. As previously discussed, a variety of resin impregnationprocesses exist. FIG. 11 shows an example of two resin impregnationprocesses that might be used to fill a produced substructure. Once asubstructure is prepared (block 316) for resin impregnation, it may bedetermined whether there is a mold available (block 318) that can beused for resin impregnation. This may be the case where, for example,the part being made is of a common size or shape, but a customsubstructure has been produced in order to provide a customized level offlexibility or rigidity throughout the structure of the part. To furtherextend this example, a mold could also be used for a part with astructure having a combined superstructure and substructure. In thisexample, the superstructure or outer layer could have a shape andgeometry that matches or fits within the mold, and the substructurecould have a shape and geometry that matches of fits within thesuperstructure. These types of structures may be useful where varyinginternal geometries and characteristics of the substructure are desired.The superstructure will fit within the mold and provide an outer layerthat is statically positioned relative to the mold, while thesubstructure within the superstructure can be statically positionedrelative to the superstructure. In this way, unique and variedsubstructures can be produced and positioned anywhere within thesuperstructure, and can maintain that position during the resinimpregnation process.

If a mold is available (block 318), the substructure can be placed(block 320) in the mold, which is partially sealed so that resin may beforced (block 322) into the mold so that it will fill the interstitialspaces of the substructure and remove the air within. Aftersubstantially all of the air has been forced out of the substructure,the resin may be cured by the passage of time, by a heating process, orby another curing process, depending upon the type and characteristicsof the resin or polymer used.

FIG. 12 shows an example of a mold-based resin impregnation processbeing performed, with a cross sectional view to show the interior of themold and part. In the shown example, a substructure having a first layer(210) and a second layer (212) of unidirectional strands, providing agrid of interstitial spaces, has been placed into a mold base (218), anda mold top (220) may be placed to seal the mold closed. Once the mold isclosed, resin is forced into the mold under pressure, forcing the airout of the interstitial spaces, where it may be released through an airrelease or output that prevents backflow. FIG. 13 shows a cross sectionof the mold with resin filling the interstitial spaces of thesubstructure, and FIG. 14 shows a cross section of the completed partremoved from the mold. As shown in FIG. 14, the interstitial spaces arenow filled with infused resin (222).

If no mold is available (block 318), which may occur when the part beingproduced is of a unique size or shape, the substructure may instead beplaced (block 324) into a vacuum bag and sealed. A vacuum source and aresin source are connected to the vacuum bag, so that when the vacuumsource is activated the air is drawn from the interstitial spaces of thesubstructure, and resin is pulled (block 322) from the resin source toreplace the displaced air. As with other processes, once the air hasbeen fully removed, the resin impregnated part may be cured (block 326)as appropriate to complete the part.

FIGS. 15 and 16 show an example of a vacuum based resin impregnationprocedure. FIG. 15 shows a cross section of interconnected poly-fibers(230) contained within a vacuum membrane (228). The vacuum membrane(228) has a resin port (224) that is connected to a source of liquidresin or polymer, and a vacuum port (226) that is connected to a sourceof vacuum pressure. When vacuum pressure is applied through the vacuumport, air is removed from the interstitial spaces (207) and liquid resinis drawn from the resin port (224) to fill the interstitial spaces(207). FIG. 16 shows a manufactured piece (232) that has been removedfrom the vacuum membrane (228) after a resin impregnation process. Theinterstitial spaces (207) around the poly fibers (230) are now filledwith infused resin (222).

FIG. 17 shows another example of a manufactured piece (232) that can becreated using an additively manufactured substructure and a resininfusion or impregnation process. Several rows of poly-fibers (230) areembedded throughout the entire structure, with each fiber (230) havingseveral changes in directionality throughout the structure. Theremainder of the manufactured piece (232) is comprised of infused resin(222) added by a process such as a vacuum bag process or a mold basedprocess. The ability to vary the directionality of poly-fibers (230)allows for the creation of substructures having complex or irregularshapes, as may be needed to create certain medical devise or componentsof medical devices.

FIGS. 18 and 19 show an additional example of a manufactured piece (234)that could be created using an embedded substructure and a resininfusion or impregnation process. A cross section of the manufacturedpiece (234) is shown, with several layers of embedded poly-fibers (230),and infused resin (222) filling in the interstitial spaces around thepoly-fibers (230). The relatively low density of poly-fibers (230)throughout the body (233) allows for some flexibility, while the neck(231) has a relatively high density of poly-fibers (230) for durabilityso that neck (231) may withstand the stresses transferred through neck(231) while still remaining narrow enough for use.

FIG. 19 shows an overhead cross-sectional view along line 19-19 of themanufactured piece (234) of FIG. 18. From that view, it can be seen thata number of vertical poly-fibers (236) run along the vertical length ofthe manufactured piece (234), and a number of horizontal poly-fibers(238) run around the circumference of the manufactured piece (234), withinfused resin (222) filling out the interstitial and surrounding spaces.As with previous examples, the changes of directionality in poly-fibers(230) shown in FIGS. 18 and 19 allow for much flexibility in the type ofsubstructure produced by the additive manufacturing system (101) thatwill, when infused with resin, have an increased strength over a purelypolymeric object or device having the same size and shape.

As already discussed, the additive manufacturing system (101) andtechniques disclosed above allow for depositions of poly-thread withvarying directionality, and a wide variation in possible substructuredesigns. Other advantages also exist and are possible to implement withthe disclosed system and techniques. For example, FIG. 20 shows a set ofsteps that may be performed using the additive manufacturing system(101) and resin impregnation techniques to produce a manufactured piecethat may have multiple zones throughout the piece, with each zone havingits own unique rigidity profile. This could include, for example, zonesthat are very rigid in response to forces from all directions, zonesthat are very flexible in response to forces from all directions, zonesthat are variably flexible or rigid depending upon the direction a forceis exerted from, or zones that allow for some level of twisting orrotation in certain directions but not others. This can be achieved byproducing, via additive manufacturing, a substructure constructed fromdifferent types of poly-fiber or from a combination of poly-fiber andfiber-less filament strands, or by producing separate sections ofinterstitial space that may receive different types of resin or polymerduring infusion or none at all, or both.

A rigidity profile may be a separate set of data from the partdefinition or may be a subset of the part definition, or both. The stepsof FIG. 20 could be performed as part of manufacturing the substructure(block 302), after receiving the part definition (block 300), andreceiving a rigidity profile (block 328). During the substructuremanufacturing process (block 302), for each strand that is deposited, adetermination will be made based upon the rigidity profile, the partdefinition, or both, whether to deposit a default strand type (e.g.,poly-fiber), or to vary the deposited strand in some way (block 330).

If the strand type needs to be varied (block 330), based on the rigidityprofile, the part definition, or both, an appropriate strand type may beselected (block 334) and readied for use. Strands could be selected inthis way by one or more of strand type, by availability, by flexibilityor rigidity requirement, or other factors. Strands could also be variedby, for example, using fibers of different diameters, using fibershaving various construction (e.g., monofilament, twisted strands),fibers containing varying materials (e.g., having a semi-rigid corematerial, having a heat resistant outer material), or by coating thefibers with the same or varying polymers (e.g., selecting polymercoatings to increase or reduce adherence with each other when placed,regardless of the material the polymer coats). A different extrusionhead (200) may be used to apply that strand, or the standard extrusionhead (200) may be cleared of the default strand automatically ormanually, and readied to deposit a different strand type. After theappropriate strand is selected (block 334), it may be deposited (block336) on the substructure or at the manufacturing area, with these stepsrepeating until the substructure is complete. The additive manufacturingsystem (101) may deposit (block 336) strands differently based upon theselected type (block 334), for example, different levels of heating,different deposition speeds, or different methods of cutting may be useddepending upon the particular strand type, in order to improveadherence, cut quality, or other characteristics for that particularstrand type.

The type and permeation of resin can also be varied throughout amanufactured piece in order to provide different levels of rigidity indifferent sections. The resin impregnation may need to be varied (block332) based upon the rigidity profile, the part definition, or both. Foreach section of the manufactured piece that has a variable resinimpregnation, a permeability will be selected (block 338) for thatsection in relation to surrounding sections. This could include, forexample, determining that a substructure wall between two sections thatwill be infused with the same type of resin should be permeable, ordetermining that a section of a substructure will not receive any resinduring impregnation, and that the substructure walls surrounding thatsection should be impermeable. In this way, different sections of thesubstructure can be walled off from others, which will allow for amulti-stage resin impregnation process to impregnate different sectionswith different types of resin or polymer, or could allow for somesections of the substructure to remain hollow through one or more resinimpregnation processes.

Once the permeability of a section has been selected (block 338), thestrands for that section may be deposited (block 339), which may includearranging strands so that the section shares interstitial spaces (i.e.,is permeable) with nearby sections, arranging strands so that thesection does not share interstitial spaces with nearby sections (i.e.,is impermeable), and may also include depositing strands to cap offcertain sections so that they are initially impermeable, but couldbecome permeable when the cap is removed during a multi-stage resinimpregnation process. Capping or blocking off certain sections to makethem temporarily impermeable may also be accomplished by using capmaterials that can be dissolved or destroyed during the process ratherthan manually removed by a person. For example, this could include capmaterials that could be dissolved in a certain solution, so that amulti-step resin impregnation process could include impregnating a firstsection with resin, dissolving one or more caps by placing the structurewithin a solution or filling or injecting the structure with a solutionwhich will make a second section permeable, and then impregnating thenow permeable sections with resin. While explained in the context of astructure having two sections, such techniques could support any needednumber of sections that could be made permeable at different timesduring a resin impregnation process, providing great flexibility duringthe process. In addition to materials that could be fully or partiallydissolved or destroyed by bathing in or filling with a solution, it iscontemplated that materials could also be used that would reactsimilarly to changes in temperatures (e.g., a section could becomepermeable when exposed to heat or cold as the cap material shrinks orexpands), forced air (e.g., pressurized air could break a cap materialwithout damaging nearby materials), or other materials that will beapparent to one of ordinary skill in the art in light of the disclosureherein.

Selection (block 338) and deposition (block 339) may repeat in thismanner until the substructure is complete (block 337). Once thesubstructure is completed, a first resin may be applied (block 340),using a resin impregnation process as previously described, to a firstset of sections. Subsequent resins may be applied (block 342) forsubstructures having different sections by uncapping or opening thosesections during the resin impregnation process that those sections areto be filled during.

Using the described techniques for varying strand types andcharacteristics, and resin impregnation types and characteristics,allows for even more flexibility in creating parts. For example, FIG. 21shows a cross section of an exemplary manufactured piece (240) made upof a plurality of fiber-poly strands having a rigid structure (242) anda plurality of polymer strands having a flexible structure (244). Theconcentration of relatively stiff poly-fiber strands (242) in thestiffened sections (246) at the four corners of the piece (240), and theconcentration of relatively flexible polymer strands (244) in theflexible section (248) of the center of the piece (240) result in a partthat is flexible through the middle and stiff at either end, such thatthe part will preferentially bend in the center while retaining itsshape at either end. This allows for the creation of medical devices orcomponents that, for example, have some flexibility in certain flexiblesections (248) that are subjected to high forces during use, such thatthey may flex slightly rather than breaking or failing, while havingstiffened sections (246) allow the device or component as a whole tohave sufficient strength and durability for its intended purpose. Thesetechniques may be useful for components that undergo high stresses thatmight cause failure in rigid components, and could include, for example,bone and structural implants for hips, shoulders, knees, and otherjoints.

FIG. 22 shows a cross sectional view of another example of amanufactured piece (250) that could be created using the disclosedtechniques for varying permeability of the created substructure. In thisexample, four outer sections of the substructure (250) are surrounded bystrands that have been deposited to form permeable walls (252) havinginterstitial spaces that will allow resin to impregnate the interior.The result of performing a resin impregnation process with the shownsubstructure (250) is that the four permeable sections will take onresin during the impregnation process and form stiffened sections (246).The center of the substructure has a ring formed by threads that havebeen deposited to form impermeable walls (254) that will prevent resinfrom entering the interior area of the impermeable walls (254) during aresin impregnation process. The result is that after resin impregnation,the interior of the impermeable walls will form a flexible section(248). The resulting manufactured piece (250) will have a hollow corewith some flexibility (254), surrounded by four stiffened sections (246)that will provide strength and durability. Alternately, rather thanleaving the flexible section hollow (248), a multi-polymer impregnationprocess could be performed to fill the flexible section hollow (248)with a more flexible type of polymer or resin that will provide somestrength when cured, but will still have relatively higher flexibilitythan the surrounding sections. As another alternative, the polymers usedin the center section and the polymers used in the exterior sectionscould be reversed, so that a set of flexible sections surround a morerigid central section.

FIGS. 23A-23D show additional examples of structures that couldincorporated into manufactured pieces using both permeable andimpermeable walls, as described above in relation to FIG. 22. Forexample, FIG. 23A shows a manufactured piece (256) with a centralsection having a smaller diameter than that shown in FIG. 22, while FIG.23B shows a manufactured piece (258) with a central section having alarger diameter than that shown in FIG. 22. FIG. 23C shows amanufactured piece (260) with a quadrilateral center section with asmall perimeter, surrounded by four outer sections, while FIG. 23D showsa manufactured piece (262) with a quadrilateral center section having alarger perimeter, such that right angles of the quadrilateral touch theouter wall of the manufactured piece (262). As with FIG. 22, any of theshown sections of the manufactured pieces (256, 258, 260, 262) may befilled with a specific type of resin, or left hollow, as may be desired,to create a manufactured piece having preferential flexibility incertain sections and in certain directions appropriate for its intendeduse. It is possible to create many types of structures beyond thoseexplicitly shown in FIGS. 21, 22, and 23A-23D with the disclosedtechniques for creating and resin impregnating substructures, and thosepieces and their characteristics and advantages will be apparent to oneof ordinary skill in the art in light of the disclosure herein.

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

An additive manufacturing system comprising: (a) a polymer diecomprising: (i) a fiber input, (ii) a heated polymer input, and (iii) apoly-fiber output, wherein the polymer die is operable to receive afiber strand from the fiber input, coat the fiber strand with a polymerfrom the heated polymer input, and extrude a poly-fiber strand from thepoly-fiber output; (b) a poly-fiber cutter positioned at the poly-fiberoutput and operable to cut the poly-fiber strand; (c) a positioningsystem operable to position and orient the poly-fiber output; (d) acontrol system comprising: (i) a processor, and (ii) memory, wherein thecontrol system is configured to control the operation of the polymerdie, the poly-fiber cutter, and the positioning system; and (e) a resininfusion system operable to fill interstitial spaces of an object with aliquid resin; wherein the control system is further configured toreceive an object definition, wherein the object definition is comprisedof a set of coordinates defining a structure for a manufactured piece,and, based on the object definition, operate the polymer die, thepoly-fiber cutter, and the positioning system to extrude, cut, anddeposit a plurality of poly-fiber strands to create the structure, andwherein the structure defines a set of interstitial spaces that, wheninfused with liquid resin by the resin infusion system and cured, areconfigured to produce the manufactured piece.

EXAMPLE 2

The additive manufacturing system of Example 1, wherein the positioningsystem is operable to deposit an uninterrupted poly-fiber strand havingone or more changes in directionality on the structure.

EXAMPLE 3

The additive manufacturing system of any one or more of Examples 1through 2, wherein the resin infusion system is of a type selected fromthe group consisting of a vacuum resin infusion system and a pressurizedresin infusion system.

EXAMPLE 4

The additive manufacturing system of any one or more of Examples 1through 3, wherein the fiber strand is of a type selected from the groupconsisting of carbon, glass, and aramid.

EXAMPLE 5

The additive manufacturing system of any one or more of Examples 1through 4, wherein the manufactured piece is a medical device component.

EXAMPLE 6

The additive manufacturing system of Example 5, wherein the medicaldevice is of a type selected from the group consisting of an implant, ahandle, a surgical material, and a grip.

EXAMPLE 7

The additive manufacturing system of any one or more of Examples 1through 6, wherein the plurality of poly-fiber strands of the structureare arranged to improve the strength of the manufactured piece.

EXAMPLE 8

The additive manufacturing system of any one or more of Examples 1through 7, wherein the structure further comprises a set of verticallydisposed poly-fiber strand layers and a set of horizontally disposedpoly-fiber strand layers.

EXAMPLE 9

The additive manufacturing system of any one or more of Examples 1through 8, wherein the control system is further configured to: (i)receive a rigidity profile and, based on the rigidity profile, determinetwo or more strand types to be deposited during creation of thestructure, and (ii) extrude, cut, and deposit the two or more strandtypes on the structure, wherein the manufactured piece is capable ofpreferential bending at one or more locations due to the placement ofthe two or more strand types.

EXAMPLE 10

The additive manufacturing system of Example 9, wherein the two or morestrand types comprise a rigid strand and a flexible strand.

EXAMPLE 11

The additive manufacturing system of Example 10, wherein a set of rigidstrands are positioned at the exterior corners of the manufacturedpiece, wherein a set of flexible polymer strands are positioned at thecenter of the manufactured piece, and wherein the manufactured piece isconfigured to preferentially bend in the center under force.

EXAMPLE 12

The additive manufacturing system of any one or more of Examples 9through 11, wherein the two or more strand types comprise asubstantially rigid poly-fiber strand and a flexible polymer strand.

EXAMPLE 13

The additive manufacturing system of any one or more of Examples 1through 13, wherein the control system is further configured to: (i)receive a rigidity profile and, based on the rigidity profile, determinetwo or more sections of the structure that should be separated by aresin impermeable wall, and (ii) extrude, cut, and deposit the pluralityof poly-fiber strands to create the resin impermeable wall, and wherein,when the structure is infused with liquid resin, a first sections of thestructure is infused with a first liquid resin and a second section ofthe structure is not infused with the first liquid resin, wherein thefirst section and the second section are separated by the resinimpermeable wall.

EXAMPLE 14

The additive manufacturing system of Example 13, wherein the secondsection of the structure is configured to be infused with a secondliquid resin when the manufactured piece is produced.

EXAMPLE 15

The additive manufacturing system of any one or more of Examples 13through 14, wherein the second section of the structure is configured toremain hollow when the manufactured piece is produced.

EXAMPLE 16

A method for producing an additively manufactured piece comprising thesteps: (a) producing a structure for a manufactured piece using anadditive manufacturing system, the structure comprising a set ofinterstitial spaces; (b) placing a plurality of poly-fiber strands onthe structure via the additive manufacturing system, wherein the act ofplacing a plurality of poly-fiber strands comprises: (i) extruding apoly-fiber strand, (ii) cutting the poly-fiber strand, and (iii)depositing the poly-fiber strand on the structure; (c) producing themanufactured piece by placing the structure in a resin infusion systemand performing a resin infusion process, wherein the resin infusionsystem fills the set of interstitial spaces with a liquid resin; and (d)curing the manufactured piece.

EXAMPLE 17

The method for producing an additively manufactured piece of Example 16,wherein the resin infusion process is a vacuum resin infusion process,and wherein the manufactured piece is produced without a casting mold.

EXAMPLE 18

The method for producing an additively manufactured piece of any one ormore of Examples 16 through 17, wherein the additive manufacturingsystem extrudes, cuts, and deposits a plurality of polymer strands,wherein the manufactured piece comprises the plurality of poly-fiberstrands and the plurality of polymer strands, and wherein themanufactured piece preferentially bends in one or more directions basedupon the placement of the plurality of polymer strands.

EXAMPLE 19

The method for producing an additively manufactured piece of any one ormore of Examples 16 through 18, wherein the structure comprises apermeable section and an impermeable section, wherein performing theresin infusion process causes the permeable section to be filled withthe liquid resin, but does not cause the impermeable section to befilled with the liquid resin, and wherein the manufactured piecepreferentially bends in one or more directions based upon the locationof the impermeable section.

EXAMPLE 20

An additive manufacturing system comprising: (a) a polymer diecomprising: (i) a fiber input, (ii) a heated polymer input, and (iii) apoly-fiber output, wherein the polymer die is operable to receive afiber strand from the fiber input, coat the fiber strand with a polymerfrom the heated polymer input, and extrude a poly-fiber strand from thepoly-fiber output; (b) a poly-fiber cutter positioned at the poly-fiberoutput and operable to cut the poly-fiber strand; (c) a positioningsystem operable to position and orient the poly-fiber output; (d) acontrol system comprising: (i) a processor, and (ii) memory, wherein thecontrol system is configured to control the operation of the polymerdie, the poly-fiber cutter, and the positioning system; and (e) a resininfusion system operable to fill interstitial spaces of an object with aliquid resin; wherein the control system is configured to receive anobject definition, wherein the object definition is comprised of a setof coordinates defining a structure for a medical device, and, based onthe object definition, operate the polymer die, the poly-fiber cutter,and the positioning system to extrude, cut, and deposit a plurality ofpoly-fiber strands and a plurality of polymer strands to create thestructure, wherein the plurality of poly-fiber strands comprises anuninterrupted poly-fiber strand having one or more changes indirectionality, wherein the structure comprises a set of interstitialspaces that, when infused with liquid resin by the resin infusion systemand cured, is configured to produce the medical device, and wherein themedical device is configured to preferentially bend in one or directionsbased upon the position of the plurality of polymer strands.

EXAMPLE 21

The additive manufacturing system of Example 20, wherein the structurecomprises a superstructure, a substructure within the superstructure,and at least one hollow within the superstructure.

EXAMPLE 22

The additive manufacturing system of any of Examples 20-21, wherein theplurality of poly-fiber strands comprise a set of poly-fiber strandshaving varying diameters, a set of poly-fiber strands having varyingmaterials, and a set of poly-fiber strands having varying polymercoatings.

EXAMPLE 23

The additive manufacturing system of an of Examples 20-22, wherein thestructure comprises a first section that is permeable, and a secondsection that is impermeable due to a cap, wherein the cap comprises amaterial that may be fully or partially dissolved in a solution to causethe second section to become permeable.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1.-20. (canceled)
 21. A method for producing a manufactured piece of amedical device, the method comprising: (a) applying a polymer to a fiberto produce a polymer coated fiber strand; (b) arranging the polymercoated fiber strand to form a structure; (c) infusing liquid resin intoa plurality of interstitial spaces of the structure; (d) curing themanufactured piece; and (e) incorporating the manufactured piece, whichincludes the polymer coated fiber strand, into the medical device. 22.The method of claim 21, wherein arranging the polymer coated fiberstrand to form the structure further comprises: (a) arranging a firstportion of the polymer coated fiber strand in a first direction; (b)arranging a second portion of the polymer coated fiber strand in asecond direction that extends along a non-zero angle relative to thefirst direction; and (c) arranging a third portion of the polymer coatedfiber strand in a third direction that extends along a non-zero anglerelative to the second direction.
 23. The method of claim 21, whereinapplying the polymer to the fiber further comprises extruding thepolymer coated fiber strand using a pultrusion process.
 24. The methodof claim 23, further comprising cutting the polymer coated fiber strandto produce a plurality of polymer coated fiber strands after extrudingthe polymer coated fiber strand and prior to arranging the polymercoated fiber strand to form the structure.
 25. The method of claim 24,wherein the plurality of polymer coated fiber strands includes first andsecond rows of polymer coated fiber strands, wherein arranging thepolymer coated fiber strand further comprises arranging the first andsecond rows of polymer coated fiber strands to extend generally parallelto each other.
 26. The method of claim 25, wherein the first and secondrows of polymer coated fiber strands have several changes indirectionality throughout the structure.
 27. The method of claim 21,wherein applying the polymer to the fiber further comprises pulling thefiber through a liquid bath containing the polymer so that the polymercompletely coats the fiber.
 28. The method of claim 21, wherein thefiber includes at least one of carbon, glass, or aramid.
 29. The methodof claim 21, wherein infusing liquid resin further comprises infusingliquid resin under a vacuum such that the manufactured piece is producedwithout a casting mold.
 30. The method of claim 21, further comprisingvarying a permeability of a portion of the structure in order toconfigure that portion of the structure to have a different subsequentrigidity.
 31. The method of claim 30, wherein the structure comprises apermeable section and an impermeable section, wherein infusing theliquid resin further comprises causing the permeable section to befilled with the liquid resin, but not causing the impermeable section tobe filled with the liquid resin.
 32. The method of claim 31, wherein themanufactured piece preferentially bends in one or more directions basedupon a location of the impermeable section.
 33. The method of claim 21,wherein the medical device is of a type selected from the groupconsisting of an implant, a handle, a surgical material, and a grip. 34.A method for producing a manufactured piece of a medical device, themethod comprising: (a) arranging at least first and second rows ofpolymer coated fiber strands to have a plurality of changes indirectionality within a structure; (b) infusing liquid resin into aplurality of interstitial spaces of the structure; (c) curing themanufactured piece; and (d) incorporating the manufactured piece, whichincludes the first and second rows of polymer coated fiber strands, intothe medical device.
 35. The method of claim 34, further comprising (a)pulling a fiber through a liquid bath containing a polymer so that thepolymer completely coats the fiber producing a polymer coated fiberstrand; and (b) cutting the polymer coated fiber strand to produce thefirst and second rows of polymer coated fiber strands.
 36. The method ofclaim 34, wherein the first and second rows of polymer coated fiberstrands to extend generally parallel to each other.
 37. The method ofclaim 34, wherein the medical device is of a type selected from thegroup consisting of an implant, a handle, a surgical material, and agrip.
 38. A method for producing a manufactured piece of a medicaldevice, the method comprising: (a) applying a polymer to a fiber toproduce a polymer coated fiber strand; (b) arranging a first portion ofthe polymer coated fiber strand along a first direction; (c) arranging asecond portion of the polymer coated fiber strand along a seconddirection that extends along a non-zero angle relative to the firstdirection; (d) arranging a third portion of the polymer coated fiberstrand in a third direction that extends along a non-zero angle relativeto the second direction, wherein the first, second, and third portionsform a structure; (e) infusing liquid resin or polymer into a pluralityof interstitial spaces of the structure; curing the manufactured piece;and (g) incorporating the manufactured piece, which includes the polymercoated fiber strand structure, into the medical device.
 39. The methodof claim 38, wherein the first portion is connected with the secondportion.
 40. The method of claim 38, wherein the polymer coated fiberstrand is embedded throughout an entirety of the structure.